PROMETHAZINE HYDROCHLORIDE syrup

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Promethazine Hydrochloride (UNII: R61ZEH7I1I) (Promethazine - UNII:FF28EJQ494)

MAH:

ATLANTIC BIOLOGICALS CORP.

INN:

Promethazine Hydrochloride

composition:

Promethazine Hydrochloride 6.25 mg in 5 mL

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Promethazine is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients. Promethazine Syrup is contraindicated for use in pediatric patients less than two years of

authorization_status:

Abbreviated New Drug Application

SPC

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SYRUP
ATLANTIC BIOLOGICALS CORP.
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PROMETHAZINE SYRUP PLAIN 6.25 MG/5 ML (PROMETHAZINE HYDROCHLORIDE
SYRUP, USP)
RX ONLY
DESCRIPTION
Each 5 mL (teaspoonful) of Promethazine contains 6.25 mg of
promethazine HCl. The
inactive ingredients present are artificial banana flavor, artificial
fruit flavor, artificial
strawberry flavor, ascorbic acid, citric acid anhydrous, dehydrated
alcohol, D&C Yellow
No. 10, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, glycerin,
liquid sugar,
methylparaben, purified water, saccharin sodium, sodium benzoate,
sodium citrate
dihydrate, and sodium propionate.
Promethazine HCl is a racemic compound; the molecular formula is C H N
S•HCl and its
molecular weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically
as 10 -
Phenothiazine-10-ethanamine, α-trimethyl-, monohydrochloride, (±)-
with the following
structural formula: _HN,N,_
Promethazine HCl occurs as a white to faint yellow, practically
odorless, crystalline
powder which slowly oxidizes and turns blue on prolonged exposure to
air. It is freely
soluble in water and soluble in alcohol.
CLINICAL PHARMACOLOGY
Promethazine is a phenothiazine derivative which differs structurally
from the
antipsychotic phenothiazines by the presence of a branched side chain
and no ring
substitution. It is thought that this configuration is responsible for
its relative lack (1/10
that of chlorpromazine) of dopamine antagonist properties.
Promethazine is an H receptor blocking agent. In addition to its
antihistaminic action, it
provides clinically useful sedative and antiemetic effects.
Promethazine is well absorbed from the gastrointestinal tract.
Clinical effects are
apparent within 20 minutes after oral administration and generally
last four to six hours,
although they may persist as long as 12 hours. Promethazine is
metabolized by the liver
to a variety of compounds; the sulfoxides of promethazine and N-
demethylpromethazine are the predominant metabo